Search Results

The EsoCheck CCD Cell Collection Device is indicated for use in the collection and retrieval of surface cells of the esophagus in the general population of adults, 22 years of age and older.

The Lucid Diagnostics EsoCheck™ CCD Cell Collection Device is a sterile single-use disposable non-endoscopic balloon capsule catheter designed to collect and retrieve surface cells of the esophagus. The balloon capsule is attached to a catheter and swallowed with the balloon deflated and inverted. Once positioned, the balloon is inflated and withdrawn allowing its textured surface to swab the surface of the targeted segment of the esophagus, retrieving cells in the process. The balloon is then deflated, retracting it along with the retrieved cells on its surface into the capsule, where they are protected from dilution or contamination as the capsule is fully withdrawn from the patient. The balloon is cut from the capsule and placed in the desired specimen container. The specimen is then sent for diagnostic processing and analysis.

The provided text describes the 510(k) premarket notification for the EsoCheck CCD Cell Collection Device. While it outlines the device's purpose, design, non-clinical tests conducted (verification and validation), and its substantial equivalence to predicate devices, it does not contain information regarding the acceptance criteria for device performance, nor details of a study that proves the device meets specific performance criteria related to diagnostic accuracy (e.g., sensitivity, specificity, or human reader improvement with AI assistance).

The document focuses on:

• Device Description: How the EsoCheck CCD Cell Collection Device works to collect esophageal cells.
• Intended Use: For collection and retrieval of surface cells of the esophagus from adults 22 years and older.
• Substantial Equivalence: Comparison to previously cleared predicate devices (Brandt Cytology Balloon, Cytosponge, Hobbs Medical Cytology Brush) based on intended use, population, anatomical location, design, principles of operation, and single-use disposition.
• Nonclinical Tests: Lists various verification (e.g., visual inspection, balloon inflation/deflation, tensile tests) and validation (biocompatibility, sterilization, shelf life, user validation) tests. These are primarily engineering and safety tests rather than performance tests for diagnostic accuracy.

Therefore, I cannot fulfill your request for the following information based solely on the provided text:

1. A table of acceptance criteria and the reported device performance: The document lists non-clinical tests but does not provide specific performance metrics (e.g., cell yield, diagnostic accuracy) or their acceptance criteria.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth and their qualifications: Not mentioned, as no diagnostic performance study is detailed.
4. Adjudication method for the test set: Not applicable based on the provided information.
5. MRMC comparative effectiveness study: Not conducted or mentioned. The device is a cell collection tool, not an AI-assisted diagnostic tool.
6. Stand-alone (algorithm only) performance: Not applicable, as it's a physical device, not an algorithm.
7. Type of ground truth used: Not mentioned.
8. Sample size for the training set: Not applicable, as there's no mention of an algorithm requiring a training set.
9. How ground truth for the training set was established: Not applicable.

The "user validation" listed under validation testing (page 5) might imply some form of study involving users, but the details (methodology, sample size, outcome metrics, acceptance criteria) are not provided in this regulatory letter and 510(k) summary. This submission is for a cell collection device based on substantial equivalence, not a novel diagnostic method requiring extensive clinical performance studies for de novo clearance or PMA.

Ask a specific question about this device

The Monarch Endoscopy Platform (Monarch Platform) and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

The Monarch™ Endoscopy Platform (Monarch Platform) is intended to be used by qualified physicians to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The Monarch Platform consists of three major components, (1) Monarch™ Endoscopy Cart, (2) Monarch™ Endoscopy Tower, and (3) Monarch™ Bronchoscope System, and working channel instruments.

The Monarch Cart provides support for the effector arms. It includes two robotic arms and the electronic systems required to power and operate the robotic system.

The Monarch Tower is the primary user (i.e. physician) procedural display interface. It contains a monitor for user viewing and computers running the system software. The tower provides connectivity for the bronchoscope camera and lighting, as well as the fluidics system. In addition, the tower includes an endoscopic controller that allows the user to control the system during a procedure.

The user controls the system with an endoscopic controller which transmits user inputs through the electromechanical system to the end effectors. The Monarch Bronchoscope System comprising of a bronchoscope and sheath is attached at the end effector of a robotic arm with multiple degrees of freedom. The flexible bronchoscope has a working channel and a camera at the tip. The bronchoscope has an articulated tip that can bend in all directions. The working channel of the bronchoscope is used for irrigation, aspiration and to deliver the working channel instruments.

The single-use manually controlled working channel instruments compatible with the Monarch Platform include the Aspirating Biopsy Needle, Biopsy Forceps, and Cytology Brush. All three have the same technological characteristics as the respective predicates and reference devices, that is, they are intended to operate in the same manner for collection of tissue or cells in the patient's lungs through a flexible endoscope or other working channel.

The Aspirating Biopsy Needle is comprised of a polymeric shaft with a needle joined to the distal end. A Luer fitting at the proximal end of the shaft allows the user to provide suction to the needle via the supplied syringe. A handle mechanism interfaces with the shaft to provide extension and retraction of the needle, and an outer jacket provides protection when the needle is not in use.

The Cytology Brush is comprised of an outer sheath and an inner catheter assembly. The inner catheter assembly consists of a thumb ring at the proximal end and a shaft to connect to the distal end which terminates in a brush. When the catheter is inserted into a working channel, the distal brush would be in a retracted position inside the outer sheath. When the catheter is in position, the brush can be extended into the tissue to obtain samples by advancing the proximal thumb ring.

The Biopsy Forceps instrument is comprised of a coil pipe with a mechanical jaw assembly joined to the distal end. The jaws are opened by sliding the outer handle component distally relative to the inner, longer handle component. The jaws are closed by squeezing the two components together.

The Monarch Endoscopy Platform (Monarch Platform) and its accessories were evaluated for safety and effectiveness through various performance tests, including biocompatibility, electrical safety, electromagnetic compatibility, software verification and validation, specific component performance testing, a navigational accuracy comparative study, animal and cadaver testing, and usability/human factors testing.

Here's a breakdown of the acceptance criteria and the studies performed, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a table format with specific quantitative targets for the Monarch Endoscopy Platform as a whole, or for each individual performance test. Instead, it states that the device "successfully tested for function, performance, and safety per FDA-recognized standards" and "complies with" or "conforms to" specific standards and design specifications. For the Navigational Accuracy Comparative Study, it mentions "substantially equivalent segmental, sub-segmental accuracy and on target accuracy, and thus equivalent Navigation Yield" compared to the predicate.

Therefore, a direct table of "acceptance criteria" and "reported performance" like for a diagnostic accuracy study is not directly extractable for every aspect. However, we can synthesize the information for the Navigational Accuracy Comparative Study:

For all other performance testing categories (Biocompatibility, Electrical Safety, EMC, Software V&V, specific component testing, animal/cadaver, usability/human factors), the acceptance criterion was "compliance with recognized standards" and "meeting intended user requirements/design specifications," and the reported performance was that the device met these.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" and corresponding sample sizes for most of the performance evaluations in terms of human subjects or distinct data points in a clinical context. The studies involved:

• Navigational Accuracy Comparative Study: The document doesn't explicitly state the sample size (number of cases or measurements) used in this comparative study.
  • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
• Animal and Cadaver Testing: Performed to evaluate the Monarch Platform under simulated use conditions.
  • Sample Size: Not specified (number of animals/cadavers).
  • Data Provenance: Prospective, simulated use.
• Usability/Human Factors Testing:
  • Sample Size: Not specified (number of representative users).
  • Data Provenance: Prospective, simulated use.
• Biocompatibility, Electrical Safety, EMC, Software V&V, and individual component performance testing: These are typically bench tests or engineering evaluations, not usually associated with a "test set" sample size in the clinical data sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document for any of the studies described. The studies appear to be primarily engineering, non-clinical (animal/cadaver), and simulated use evaluations rather than studies requiring expert adjudication of ground truth for diagnostic accuracy in patient data.

4. Adjudication Method for the Test Set

Since the document does not describe studies involving human medical experts establishing ground truth for a diagnostic test set, there is no mention of an adjudication method (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned in the provided text. The "Navigational Accuracy Comparative Study" compares the Monarch Platform's navigation metrics to the superDimension™ System, but it's not described as an MRMC study and therefore no effect size of human readers improving with AI vs. without AI assistance is provided. The Monarch Platform is described as a robotic endoscopy system that assists physicians, but the focus of the performance data section is on the device's inherent capabilities and comparison to existing technologies, not on augmented human performance in an MRMC setting.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The performance testing section primarily describes standalone performance aspects of the Monarch Platform and its accessories (e.g., biocompatibility, electrical safety, software V&V, mechanical performance of instruments, navigational accuracy of the system). The navigational accuracy study comparing Monarch and superDimension™ evaluates the system's navigation performance itself. The animal, cadaver, and usability studies involve human users but evaluate the system's safety and effectiveness with human interaction, not a standalone algorithm's diagnostic performance in the absence of human input.

Therefore, while the individual component and software testing represent "standalone" evaluations of those specific parts, a standalone diagnostic algorithm performance study (without human-in-the-loop) for a clinical outcome is not explicitly detailed as described for typical AI/ML devices. The Monarch Platform is a surgical robotic system with navigation features, so its "standalone" performance relates to its ability to perform its function (e.g., navigate, manipulate instruments) rather than to interpret images or diagnose conditions like a standalone AI diagnostic software.

7. The Type of Ground Truth Used

For the specific tests mentioned:

• Navigational Accuracy Comparative Study: The "ground truth" for navigation metrics (segmental, sub-segmental accuracy, on-target accuracy, distance to target) would likely be established through precise measurements against a known anatomical model or imaging data, but the document does not specify the exact method for this ground truth establishment.
• Animal and Cadaver Testing: Ground truth established through observation of the system's performance and impact on the tissues/anatomy, likely assessed by skilled medical professionals involved in the study.
• Usability/Human Factors Testing: Ground truth related to user needs, safety, and effectiveness is established through defined task completion rates, error rates, and user feedback against pre-defined success criteria.
• Other performance tests (biocompatibility, electrical safety, etc.): Ground truth is established by adherence to recognized international standards and engineering specifications.

8. The Sample Size for the Training Set

The document does not mention a training set size. This is expected as the Monarch Platform is described as a robotic surgical system with navigation, not a machine learning or AI diagnostic device that typically requires a large training set of annotated data for model development. The software verification and validation are mentioned, but this refers to traditional software development and testing, not AI/ML model training.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned in the context of an AI/ML model, there is no information on how its ground truth was established.

Ask a specific question about this device

To be utilized through a flexible endoscope or the superDimension system by physicians who are trained in endoscopic techniques for retrieving specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses.

The superDimension® Triple Needle Cytology Brush is designed to obtain tissue samples for biopsy from endobronchial lesions, peripheral lung nodules, or lung masses. The superDimension® Triple Needle Cytology Brush is an endoscopic catheter comprised of an outer Ethylene Tetrafluoroethylene (ETFE) sheathing and an inner catheter assembly. The inner catheter assembly consists of a thumb ring at the proximal end and a twisted wire shaft to connect to the distal end. The distal end terminates in three connected brushes available in two lengths: 10 mm and 15mm. The brushes have sharpened ends, referred to as needle-tipped, that can be used to rough up tissue to obtain a sample of tissue or cells. When the catheter is inserted into a channel such as a bronchoscope or superDimension Extended Working Channel (EWC) with the distal brush in a retracted position inside the outer sheath. When the catheter is in position, the brushes can be extended into the tissue to obtain tissue samples by advancing the proximal thumb ring. When the physician believes that an adequate sample has been taken, the brushes are retracted back into the sheath and then the entire catheter is withdrawn from the channel The superDimension® Triple Needle Cytology Brush is for standard tissue analysis. similar to currently marketed cytology brushes except that it has three smaller brushes in place of one larger brush.

The provided text describes the 510(k) summary for the Covidien SuperDimension® Triple Needle Cytology Brush. Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of quantitative acceptance criteria with specific numerical thresholds for performance metrics. Instead, it states that the device "met the required specifications for the completed tests and performed similarly to the predicate devices." The performance evaluation is based on demonstrating substantial equivalence to predicate devices, rather than achieving pre-defined quantitative performance targets.

However, based on the described "Performance Data," we can infer the categories of performance evaluated:

• Catheter tensile strength
• Dimensional accuracy
• Ability to simulate use cases
• Trackability | Met required specifications; similar to predicate devices. |
  | Durability/Stability| - Shelf life (per ASTM F1980-07, ASTM F2096-11, and ASTM F88-09)
• Distribution integrity (per ASTM D4169-09) | Met required specifications; similar to predicate devices. |
  | Sterilization | - Sterility (per ISO 11135-1) | Met required specifications; similar to predicate devices. |
  | Biocompatibility | - Cytotoxicity, irritation, sensitization (per ISO 10993-1, ISO 10993-5, ISO 10993-7, ISO 10993-10) | Met required specifications; similar to predicate devices. |
  | Functional (In Vivo)| - Ability to collect tissue specimens
• Safety (no adverse events/complications in the animal model) | Demonstrated tissue collection and safety in a porcine model; similar to predicate devices. |

2. Sample Size Used for the Test Set and the Data Provenance:

The document mentions "In-vitro and in-vivo testing" was performed, but does not specify the sample sizes used for these tests. For the in-vivo testing, it was conducted "in a porcine model," indicating an animal study, not human data. The data provenance is described as:

• In-vitro testing: Laboratory-based, likely conducted by the manufacturer.
• In-vivo testing: Porcine model (animal study).

There is no mention of human retrospective or prospective data for the performance evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This information is not provided in the document. Given that the testing involved in-vitro and in-vivo (animal model) studies, the "ground truth" would likely be established through objective measurements (for in-vitro tests) and pathological examination of collected animal tissue, possibly by veterinarians or animal pathologists. However, the specific number and qualifications of experts are not stated.

4. Adjudication Method for the Test Set:

This information is not provided. As the testing primarily involved objective measurements and animal studies, a formal adjudication method for human consensus on ground truth (like 2+1 or 3+1) would not be applicable in the absence of human clinical data or expert evaluation of test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done, nor is there any mention of AI assistance in this context. The device described is a physical medical instrument (cytology brush), not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This question is not applicable as the device is a physical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

Based on the described testing:

• For in-vitro tests, the ground truth would be based on objective physical and material measurements against established engineering specifications and industry standards.
• For in-vivo testing in a porcine model, the ground truth for tissue collection would likely be pathological examination of collected animal tissue samples to confirm the presence and adequacy of collected cells/tissue. Safety would be assessed through observation and potentially post-mortem examination.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical instrument, and there is no mention of an algorithm or AI model that requires a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as there is no training set mentioned for this physical device.

Ask a specific question about this device